RIMADYL AQUEOUS Injection

Država: Južnoafriška republika

Jezik: angleščina

Source: South African Health Products Regulatory Authority (SAHPRA)

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Prenos Lastnosti izdelka (SPC)
27-06-2022

Dostopno od:

Zoetis South Africa (Pty) Ltd

Odmerek:

See ingredients

Farmacevtska oblika:

Injection

Sestava:

Each 1.0 ml Solution contains CARPROFEN A 50.0 mg

Terapevtsko območje:

C 3.1.1 Steroidals

Status dovoljenje:

Registered

Datum dovoljenje:

2009-03-08

Lastnosti izdelka

                                _ _
Page 1 of 5
_ _ PACKAGE INSERT
VETERINARY MEDICINE
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
RIMADYL Aqueous Injection (Injection)
COMPOSITION
Each ml contains 50 mg carprofen.
Preservatives: Ethanol 0,1 mg/ml and benzylalcohol 10 mg/ml.
PHARMACOLOGICAL CLASSIFICATION
C 3.1.2.2 NSAIDs, Selective COX2 inhibitors
PHARMACOLICAL ACTION:
Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent
with characteristic analgesic
and antipyretic activity.
The exact mode of action of carprofen has not been established,
however, inhibition of
prostaglandin synthesis accounts for at least part of its mechanism of
action. Carprofen is a
moderately potent inhibitor of phospholipase A
2
and a reversible inhibitor of cyclo-oxygenase
(COX). In _ in-vitro_ cell-culture of canine origin, carprofen
displayed selectivity for COX-2, the
inducible form of the enzyme upregulated in damaged and inflamed
tissue, compared with its
inhibition of COX-1, the iso-enzyme which is involved in normal
gastric function. Carprofen has
also been shown to inhibit the release of prostaglandins in acute
polymorphonuclear leukocyte
and chronic inflammatory reactions.
Carprofen has modulatory effects on both humoral and cellular immune
responses. It inhibits
the production of osteoclast-activating factor (OAF), PGE
1
, and PGE
2
, by its inhibitory effects on
prostaglandin biosynthesis.
PHARMACOKINETIC PROPERTIES AND PHARMACODYNAMIC PROPERTIES
Calves below 12 months of age:
S3
_ _
Page 2 of 5
_ _
Carprofen exhibits age dependent pharmacokinetics, such that the
half-life in calves with mean
bodyweight of 68 kg is approximately 111 hours which is decreased to
approximately half that
value (61 hours), for calves with a mean bodyweight of 90 kg and
beyond. Despite this, no
difference has been seen in the duration of clinical efficacy in young
cattle between 1 and 48
weeks of age. In a study in calves of thirteen weeks of age the
following kinetic parameters
were determined:
Absorption: Following a single subcutaneous injection of 1,4 mg/kg
                                
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